Why it was recalled
Failed dissolution specifications
Product description
Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11
Lot numbers, UPCs & expiration codes
Lot #140849
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1140-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 2, 2015
- FDA report date
- Jun 24, 2015
- Quantity
- 925 cartons (30 tablets in each carton)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1140-2015, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 71219
- Address
- 2550 John Glenn Ave
- Address (line 2)
- Suite A
- Code information
- Lot #140849
- Postal code
- 43217-1188
- Report date
- Jun 24, 2015
- Product type
- Drugs
- Recall number
- D-1140-2015
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 925 cartons (30 tablets in each carton)
- Termination date
- Oct 9, 2015
- Reason for recall
- Failed dissolution specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 2, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 16, 2015